Method for removing verrucae



United States Patent METHOD FOR REMOVING VERRUCAE Marvin D. Steinberg,Eastchester, N. Y.

No Drawing. Application November 12, 1952, Serial No. 320,116

3 Claims. (Cl. 16758)- This invention relates to the process for thetreatment and removal of plantar, subungual and other cutaneous verrucaeand to the materials employed for said purpose.

Verrucae are warty growths on the skin and are thought to be of viraloriginal. There are many types of verrucae; common forms are found onthe soles of the feet where they are most disabling and generallydifiicult to treat and resistant to therapeutic measures. This type isknown as plantar verrucae. Another form are the subungual type whichcauses deformities of the nails of the fingers and toes. Mosaic verrucaeare still another form occurring in patches on the skin of the soles ofthe feet and are characterized by spreading over a large area sometimesthe size of a half-dollar. This type is also very resistant to ordinarymethods of therapy.

All verrucae and especially those occurring subungually, plantarly andthe mosaic group are a therapeutic problem in general medical,dermatological and podiatry practice. These lesions are frequentlydisfiguring, disabling and many times constitute a source of severe painand suffering to those afflicted.

The customary treatment of this condition involves a gamut of commonmeasures including psychotherapy, chemical caustics, X-ray exposure andsystemic therapy. Many exotic and strange charms and psychotherapeuticmeasures have been claimed as etficaceous in the removal of verrucae.Obviously none of these measures have been found satisfactory whensubjected to clinical investigation.

A common form of treatment has been the local application of causticchemical agents such as trichloracetic acid, nitric acid, salicylicacid, silver nitrate, pyrogallic acid, etc. The local application ofthese caustic agents destroy or dissolve the tissues involved in thelesions and many times diffuse into surrounding normal tissue causingsevere chemical burns and painful reactions. This type of treatment maybe effective in the superficial types of verrucae, however, they cannotbe relied upon to remove the more resistant and deep seated forms.

Electrodesiccation or fulguration is used extensively for the removal ofverrucous lesions and in skilled hands may be considered the best of thecommonly available therapeutic measures. However, there are seriousdisadvantages to this type of treatment among which are the need forbandaging, the absence of bathing or other contact with water of thehealing wound, which in reality is a slow healing third degree burn.When large areas are removed in this manner healing may take from 6Weeks to 3 or 4 months. Another objection is that a scar remains aftersuch healing. The scar may be disfiguring, annoying or painfulespecially when on the soles of the feet or finger tips and when thepatient tends toward keloid formation.

Radiation by X-ray, radium or other radioactive substances has become apopular mode of therapy despite the serious risks involved. Manyauthorities on neoplastic diseases state that under no circumstancesshould X-ray therapy be used for such lesions of the hands or feet. Ihave seen hundreds of tragic sequelae of radiation therapy ranginganywheres from the production of a local 2,730,901 Patented Aug. 28,1956 but exquisitely painful radio-dermatitis or radio-ulcer to squamouscell carcinoma of the skin, destruction of deep structures and mattingtogether of the entire post radiation burn to the underlying tendons andbony structures. Such complications following radio-therapy haveresulted in amputations of the extremities. It should be borne in mindthat that radiation is cumulative, causes mutatious cell changes and inchildren affects the growth centers of underlying bony structurescausing disturbances in size of a limb. Such bad eifects may only befirst noticed twenty years after the original therapy.

Use has been made of such agents as arsenic, bismuth,- mercury andvarious other medicinal agents taken internally or by intra-muscularinjection. No consistent favorable results have been obtained for thistype of therapy. Such therapy involves considerable risk to the patientas the medicaments employed are usually strongly toxic agents.

It is obvious from the above that there is a vast armamentarium oftreatments which have or are being used and which clearly indicates thatin the prior art there is no one effective and completely satisfactorytreatment for this condition.

I have found a new and satisfactory treatment for all the verrucae abovedescribed and especially eflicacious against the highly resistant,recurrent and deep seated forms. This new treatment involves theapplication of a solution containing a relatively high concentration ofVitamin A into and around the lesion.

The technique which I have used with great success is as follows: (1)Asepticaliy prepare the skin immediately surrounding the lesion, (2) drythe area with sterile gauze and produce a topical anesthesia by sprayingwith ethyl chloride preliminary to insertion of the hypodermic needle,(3) plunge the needle (25 gage-% inch) of the hypodermic syringecontaining the solution of Vitamin A through the edge and into the baseof the verruca, (4) carefully adjust the point of the needle so that itis directed at and into the lesion at the deep epidermal level, (5) pullback on the plunger to make certain that the needle is not ina bloodvessel, (6) infiltrate the injection solution slowly throughout thelesion, (7) leave needle in place for 30 seconds to prevent back flowand then remove needle and place a sterile, non-medicated band-aid overthe puncture site.

The solution of vitamin A which I prefer to use in the hypodermicsyringe above mentioned is'an aqueous dispersion of vitamin A of astrength of 5,000 to 50,000 units containing 2% procaine HCl. The dosageused depends on the size and typed verruca but in generalabout 10,000 to50,000 units per milliliter of injection solution per treatment: issatisfactory.

The above example is a preferred technique of applying the invention butmany variations are possible without departing from the scope of theappended claims. For instance, non-aqueous solutions of vitamin A may beemployed with good results. When non-aqueous solutions, such assolutions of vitamin A dissolved in a fatty oil, are employed I preferto inject into the area a preliminary anesthetizing solution 'ofprocaine HCl before the vitamin A. In order to avoid two needlepunctures at the site of the lesion, the needle is left in situ and thefirst hypodermic syringe is removed and replaced with the syringecontaining the vitamin A. Solutions of vitamin A in sesame oil at alevel of 25,000 to 50,000 units per milliliter have been found to beabout optimum but higher or lower concentrations may be used at thediscretion of the operator.

The aqueous dispersions of vitamin A are prepared by the incorporationof a surface active material before dispersion in water. The use ofpolyoxyethylene sorbitan monolaurate, a product commercially known asTween is used to prepare a commercially available aqueous vitamin Adispersion.

The use of these aqueous dispersions of vitamin A avoids some of theloca reactions encountered when a fatty oil base is used. I prefer touse the aqueous dispersions in which an anesthetic, such as procaineHCl, is dissolved. Other additions may be made to this aqueousdispersion such as adrenalin to act as a hemostatic agent to slow downabsorption of the injected solution or sodium ascorbate which acts as anantioxidant preventing loss of the vitamin A during sterilization orDepending on the size and type of lesion, the a cunt of vitamin Adispersion injected will vary from about 0.05 to 1.0 milliliter ofstrengths varying from about 1,000 to 100,000 or more units of vitamin Aactivity. In cases where higher doses are indicated, the pure vitamin P;v be injected; this has an activity of about 1,7 per milliliter. Forsubungual lesions I have generally found it advisable to limit thevolume of the injected solution to 0.1 milliliter.

A variation of the above technique using the aqueous dispersion or thepure vitamin is to divide the treatment into two separate injections.First injecting a solution of a local anesthetic such as procaine HCland then following with the vitamin A injection after the area isanesthetized. In this way better control over the exact location of thepoint of the hypodermic needle and the direction and distribution of thevitamin A in the lesion is obtained without discomfort to the patient.

Another variation in the technique is the topical application of vitaminA to the lesion both by itself or combined with the injection treatment.For topical application I have used the pure undiluted vitamin A or itssalts such as the palmitate, alone or in combination with a keratolyticagent, such as salicylic acid. To further help in the penetration i alsoadd surface active agents such as Tween or one of the quaternaryammonium derivatives now available as a surface active agent andgermicide. By the combined use of the injection treatment with thetopical application an increased action is obtained resulting in thelesions undergoing the changes described below at a more rapid rate.Many verrucae are amenable to treatment by the topical applicationtechnique by itself. This mode of treatment avoids the discomfort at thetime of treatment due to the insertion of the hypodermic needle.

Generally a series of three injections are given at weekly intervals atthe dosage levels given above and in accordance with the size of theverruca. However, the number of injections may be reduced or increasedby varying the dosage level per injection respectively or in accordancewith the response of the lesion to treatment. Following the injectionscertain changes begin, enumerated they are: (l) a moderate to hardlynoticeable inflammatory reaction occurs, (2) coinciding with thesubsidence of the inflammatory reaction local itching occurs, (3) lesioninvolutes by first regressing in size, losing its characteristic rugosesurface, diminishing vascularity and desquamation of overlyinghyperkeratotic plaques, (4) upon complete regression of the lesion theskin assumes a normal appearance, the papillary lines reappear and noscarring ensues. From studies of the fluorescence of the lesions inultra violet light it appears that the abnormal tissue comprising theselesions specifically absorbs the vitamin A from the surrounding areas.The high concentrations of absorbed vitamin A probably changes theabnormal metabolism of the verrucous tissue causing it to regress andform normal skin tissue underneath without scarring.

The above disclosure represents the essential features of this inventionbut many variations are still possible to those skilled in the artwithout departing from the scope and general idea of the treatment andmaterials used therein. The term, vitamin A includes the natural orsynthetic vitamin or its precursors, derivatives such as the acetate orpalmitate, non-aqueous solutions prepared, for instance, with fatty oilssuch as sesame oil and aqueous dispersions of the vitamin prepared withthe aid of suitable surface-active or dispersing agents common to theart.

I claim:

1. In the treatment of verrucae, the step which comprises injectingdirectly into the veriucae a vitamin A compound of the group consistingof vitamin A and the fatty acid esters thereof.

2. The step in the treatment of verrucae as defined in claim 1 in whichthe vitamin A compound is injected in the form or an aqueous dispersion.

3. The step in the treatment of verrucae as defined in claim 1 in whichthe vitamin A compound is vitamin A palmitate.

References Cited in the file of this patent UNITED STATES PATENTS1,627,963 Fuller May 10, 1927 2,381,830 Lobel Aug. 7, 1945 2,417,299Freedman Mar. 11, 1947 2,592,149 Jacobson Apr. 8, 1952 OTHER REFERENCESU. S. Dispensatory, 24th ed., J. P. Lippincott, Philadelphia, 1947, pp.934, 935, 999.

Physicians Bulletin, Sept-Oct. 1951, pp. 117.

l. A. M. A., vol. 139, No. 9, p. 615.

Allington: A. M. A. Archives Dermatology and Syphilology, Sept. 1952,vol. 66, No. 3, pp. 316326.

Ignatoff: J. Nat. Assoc. Chiroprodists, vol. 44, No. 7, pp. 37, 41, 43(1954).

Branson et al., ibid., pp. -66.

Digest of Treatment, January 1950, pp. -101.

1. IN THE TREATMENT OF VERRUCAE, THE STEP WHICH COMPRISES INJECTINGDIRECTLY INTO THE VERRUCAE A VITAMIN A COMPOUND OF THE GROUP CONSISTINGOF VITAMIN A AND THE FATTY ACID ESTERS THEREOF.